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The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
A novel device for left atrial appendage exclusion
Keiji Kamohara1, Kiyotaka Fukamachi, Yoshio Ootaki
1Biomedical Engineering, The Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA.
Insights
A novel device safely and effectively excludes the left atrial appendage, a common source of stroke in atrial fibrillation patients. This occlusion technique offers a promising new therapeutic option to reduce stroke risk.
Area of Science:
- Cardiovascular Surgery
- Medical Devices
- Thrombosis Research
Background:
- The left atrial appendage is a primary source of thromboemboli in patients diagnosed with atrial fibrillation.
- Exclusion or excision of the left atrial appendage is a potential strategy to mitigate stroke risk in this patient population.
Purpose of the Study:
- To evaluate the efficacy and safety of a novel device designed for left atrial appendage exclusion.
- To assess the performance of this device in early and intermediate follow-up periods within a canine model.
Main Methods:
- Eight mongrel dogs underwent implantation of a novel occlusion device at the left atrial appendage base via left thoracotomy on a beating heart.
- Post-implantation evaluation included epicardial echocardiography, left atrial angiography, histologic inspection, and gross pathology at 7, 30, and 90 days.
Main Results:
- Device implantation was successfully completed in all subjects without complications.
- Echocardiographic and angiographic assessments confirmed complete and sustained exclusion of the left atrial appendage from circulation.
- No instances of device migration or damage to adjacent cardiac structures were observed.
Conclusions:
- The novel device facilitates rapid, reliable, and safe exclusion of the left atrial appendage.
- This innovative device presents a new therapeutic avenue for reducing stroke risk in patients with atrial fibrillation.
Objective:
The left atrial appendage is a frequent source of thromboemboli in patients with atrial fibrillation. Exclusion or excision of the left atrial appendage may reduce the risk of stroke in patients with atrial fibrillation. We evaluated the ability of a novel device to exclude the left atrial appendage during early and intermediate follow-up periods in a canine model.
Methods:
Eight mongrel dogs (mean weight 29.1 +/- 4.0 kg) were used in this study. The occlusion device, constructed from 2 stainless steel strips covered with a knit braided polyester fabric, was implanted at the base of the left atrial appendage through a left thoracotomy on a beating heart. Dogs were evaluated at 7 days (n = 2), 30 days (n = 2), and 90 days (n = 4) by epicardial echocardiography, left atrial angiography, histologic inspection, and gross pathology.
Results:
Device implantation was performed without complications in all animals. Complete exclusion of the left atrial appendage from the circulation was confirmed acutely and chronically by echocardiographic and angiographic evaluations. There was no device migration or damage to adjacent structures.
Conclusion:
This novel device enables rapid, reliable, and safe exclusion of the left atrial appendage. The device provides a new therapeutic option for reducing the risk of stroke in patients with atrial fibrillation.

